(HealthDay News) — For patients with type 2 diabetes, the incidence of major cardiovascular events is similar for those receiving exenatide or placebo, according to a study published online in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the European Association for the Study of Diabetes, held from Sept. 11 to 15 in Lisbon, Portugal.
Rury R. Holman, FMedSci, from the University of Oxford in the United Kingdom, and colleagues randomized 14,752 patients (73.1% with previous cardiovascular disease) with type 2 diabetes to receive extended-release exenatide or placebo once weekly.
The researchers found that 11.4% of patients in the exenatide group and 12.2% in the placebo group had a primary composite event (hazard ratio, 0.91; 95% confidence interval, 0.83 to 1.00); in the intention-to-treat analysis, exenatide was non-inferior to placebo with respect to safety (P < 0.001), but was not superior with respect to efficacy (P = 0.06). There was no significant difference between the groups in the rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, heart failure hospitalization, or acute coronary syndrome hospitalization.
“Once-weekly administration of extended-release exenatide in patients with type 2 diabetes at a wide range of cardiovascular risk appeared not to cause an increase in their overall cardiovascular risk,” the authors write.
The study was funded by Amylin Pharmaceuticals, a wholly owned subsidiary of AstraZeneca, the manufacturer of exenatide.
- Holman RR, Bethel MA, Mentz RJ, et al. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. New Engl J Med. doi: 10.1056/NEJMoa1612917